As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Tiao Peng Trading Inc.
Hayward, CA
A food firm in Hayward, CA, is on notice from the FDA for not implementing Foreign Supplier Verification Program (FSVP) regulations for a number of their products.
In a May 19 warning letter, the FDA described a Jan. 14-17 Foreign Supplier Verification Program inspection at Tiao Peng Trading Inc., as well as an initial inspection on Sept. 12, 2017. Inspectors found that the company was not in compliance with FSVP regulations.
FDA’s inspection resulted in issuance of an FDA Form 483.
The significant FSVP regulation violations noted are as follows:
- The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Canned black beans, canned red beans, and canned fruit imported from (redacted), located in (redacted).
- Fish snack foods imported from (redacted), located in (redacted).
- Custard cake imported from (redacted), located in (redacted).
- For thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods). They did not verify and document that their curry gravy, a low‐acid canned food.
- They must approve their foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. The firm did not document their approval of their foreign suppliers of curry gravy and tom yum soup paste imported from (redacted).
- The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their use of these procedures.
- They did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods they import.
- The firm did not conduct and document (or obtain documentation of) one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter. For example, they did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for their foreign supplier (redacted) before importing pickled mustard and periodically thereafter, for their foreign supplier (redacted) before importing tom yum soup paste and periodically thereafter, or for their foreign supplier (redacted) before importing curry gravy and periodically thereafter.
The full warning letter can be viewed here.
Express Trading International Inc.
San Diego, CA
A food firm in San Diego, CA, is on notice from the FDA for not implementing FSVP regulations for several of their products.
In a July 2 warning letter, the FDA described a Feb.19 Foreign Supplier Verification Program inspection at Express Trading International Inc. as well as an initial inspection on July 17, 2018. Inspectors found that the company was not in compliance with FSVP regulations.
FDA’s inspection resulted in issuance of an FDA Form 483.
The significant FSVP regulation violations noted are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Canned Coconut Milk imported from (redacted), located in (redacted).
- Aloe Vera Drink Pomegranate products imported from (redacted), located in (redacted).
The full warning letter can be viewed here.
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